Model Number 66800280 |
Device Problems
Loss of or Failure to Bond (1068); Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/22/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Internal complaint reference number: (b)(4).
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Event Description
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It was reported that many pieces of the adhesive edge of the allevyn gentle border dressings come loose in several sizes.It sticks to the sink and the floor.This happened specially to the bottom and sides of the patches.It is unknown if a patient was involved.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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All supplied information has been reviewed and we were unable to establish a relationship between the device and the reported event or to determine a root cause.Probable root causes may include storage temperature or component failure.No lot/batch number has been provided, therefore a review of the manufacturing records is not possible.A complaint history review found further instances of the reported event.This investigation is now complete with no further action deemed necessary at this stage.Smith + nephew are taking further actions relating to the failure reported and continue to monitor for adverse trends.
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Search Alerts/Recalls
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